Contains Nonbinding Recommendations.
Comments and suggestions regarding this document may be submitted at any time. Submit comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with the Docket Number 2004D-0487.
For questions regarding this document contact the Center for Food Safety and Applied Nutrition, at 240-402-2375.
This guidance represents the Food and Drug Administration's (FDA's) current thinking on the topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations.
The Food and Drug Administration (FDA) receives many questions about the labeling of dietary supplements. These questions are a consequence of the activity in this area over the past several years. Some of the important events relating to the labeling of dietary supplements include:
- The Nutrition Labeling and Education Act of 1990 amended the Federal Food, Drug, and Cosmetic Act (the act) in a number of important ways. Notably, by requiring that most foods, including dietary supplements, bear nutrition labeling.
- The Dietary Supplement Health and Education Act of 1994 (the DSHEA) amended the act, in part, by defining "dietary supplements," adding specific labeling requirements for dietary supplements, and providing for optional labeling statements.
- On September 23, 1997 (62 FR 49826), we implemented the DSHEA by publishing several key regulations on the statement of identity, nutrition labeling, ingredient labeling, and nutrient content and health claims for dietary supplements. On June 5, 1998 (63 FR 30615), we amended the regulations pertaining to the nutrition labeling of extracts used in dietary supplements.
- On January 15, 1997 (62 FR 2218), we published regulations that require a label warning statement on dietary supplements with added iron. These regulations also required the unit-dose packaging of supplements containing 30 milligrams or more, but this requirement has been eliminated as a result of a court challenge in January, 2003.
- On July 11, 2003 (68 FR 41434), we published a final regulation that amended the labeling requirements for dietary supplements, as well as for conventional foods, that would make the declaration of trans fat mandatory in nutrition labeling. This regulation requires that, when present at 0.5 g or more, trans fat be listed in the Supplement Facts panel of dietary supplements on a separate line under the listing of saturated fat by January 1, 2006.
We have prepared this guide to help assure that the dietary supplements sold in the United Stated (U.S.) are properly labeled. This guide applies to dietary supplements produced domestically as well as those produced in foreign countries. Under our regulations, label approval is not required to import or distribute a dietary supplement.
We have included the most frequently raised questions about the labeling of dietary supplements using a "question and answer" format. If you have a question not addressed in this guide, please contact an FDA District Office (see Appendix A of this guide) or the:
Division of Dietary Supplement Programs (HFS-810)
Office of Nutritional Products, Labeling, and Dietary Supplements
Center for Food Safety and Applied Nutrition
Food and Drug Administration
5001 Campus Drive
College Park, MD 20740-3835
Please be advised that you must comply with any requirements for dietary supplements that may publish after this booklet is issued. New regulations are published in the Federal Register prior to their effective date and are compiled annually in Title 21, Part 101 of the Code of Federal Regulations (21 CFR 101). Summaries of our new regulations (proposed regulations and final regulations) are posted on our Internet Website (http://www.fda.gov).
FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word "should" in agency guidances means that something is suggested or recommended, but not required.
- General Dietary Supplement Labeling
- Identity Statement
- Net Quantity of Contents
- Nutrition Labeling
- Ingredient Labeling
- Pre-market Notification of New Dietary Ingredients
- Other Labeling Information
- FDA District Offices
- Daily Values for Adults and Children 4 or More Years of Age (also known as Food Labeling Guide Reference Values)
- Daily Values for Infants, Children Less Than 4 Years of Age, and Pregnant or Lactating Women
- Nutrient Content Claims (Includes Food Labeling Guide Appendix A and B)
- Authorized Health Claims (Includes Food Labeling Guide Appendix C and FDAMA claims)
- Qualified Health Claims
|Alternate principal display panel||Chapter I|
|"And/or" labeling of fat and oil ingredients||Chapter V|
|Antioxidant claims||Chapter VI|
|Artificial colors||Chapter V|
|Artificial flavors||Chapter V|
|Bulk containers||Chapter IV|
|Chemical preservatives||Chapter V|
|Common or usual name||Chapters II and V|
|Conspicuousness||Chapters I and III|
|Country of origin||Chapter I|
|Daily Values||Chapter IV|
|Definition of dietary supplements||Chapter I|
|Degree of Prominence||Chapter I and II|
|Descending order of predominance||Chapter IV and V|
|Determining the net quantity||Chapter III|
|Dietary ingredients||Chapters I, II,IV, V, VI and VII|
|Different package sizes||Chapter III|
|Disclosure statements||Chapter VI|
|Exemptions from nutrition labeling||Chapter IV|
|Expiration dating||Chapter I|
|Folic acid||Chapter VIII|
|Format of "Supplement Facts" panel||Chapter IV|
|"Free" claims||Chapter VI|
|"Good source" claims||Chapter VI|
|Health claims||Chapter VI|
|"High potency" claims||Chapter VI|
|Incidental additives||Chapter V|
|Information panel||Chapter I|
|Ingredient list||Chapter V|
|Iron-containing dietary supplements||Chapter VIII|
|Label statements||Chapter I|
|Latin names||Chapter IV|
|Name and address||Chapter I|
|"Low" claims||Chapter VI|
|Name of dietary supplement||Chapter II|
|Natural flavors||Chapter V|
|Net quantity of contents statement||Chapter III|
|New dietary ingredient||Chapter VII|
|New dietary supplements||Chapter VII|
|Notification for a claim||Chapter VI|
|Nutrient content claims||Chapter VI|
|Nutrition labeling||Chapter IV|
|Nutrition labeling exemptions||Chapter IV|
|Omega-3 fatty acids||Chapter VI|
|Other dietary ingredients||Chapter IV|
|Ounces and grams||Chapter III|
|Percent of Daily Value||Chapter IV|
|Percentage claims||Chapter VI|
|Placement of statement of identity||Chapter II|
|Premarket notification||Chapter VII|
|Principal display panel||Chapter I and III|
|Proprietary blends||Chapter IV|
|Section 403(r)(6) claims||Chapter VI|
|Serving sizes||Chapter IV|
|Small packages||Chapter IV|
|Special labeling provisions||Chapter VI|
|Statement of identity||Chapter II|
|Structure/function claims||Chapter VI|
|"Supplement Facts"||Chapter IV|
|Trans fat||Chapter IV|
|Type size||Chapters I - VI|
|Warning statement about iron||Chapter VI|